- There Were No Differences in RFS Regarding Usage for
Chemoablation or Post-Endoscopic Ablation, Tumor Size,
Multifocality, or Tumor Location
- RFS Was 100% in Patients who Received Maintenance therapy vs
61% for Patients Who Did Not Receive Maintenance Therapy
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing novel solutions that treat
urothelial and specialty cancers, today highlights the results of a
sub-analysis from the first and largest real-world patient cohort
review of JELMYTO (mitomycin) for pyelocalyceal solution presented
at the American Urological Association Meeting 2024 in San Antonio,
TX. Among patients with low-grade Ta upper tract urothelial
carcinoma (UTUC) who were complete responders to induction therapy
(n=53), JELMYTO was associated with an 86% recurrence-free survival
rate at 24 months across diverse patient types regardless of
initial disease characteristics or usage for chemoablation versus
post-endoscopic ablation. Among the 30% of the complete responders
who received maintenance therapy, RFS at 24 months was 100%, vs.
61% for those who did not receive maintenance therapy.
“The 86% recurrence-free survival rate at the 24-month mark
among low-grade UTUC patients (n=53) exhibited a favorable response
to the initial induction of this new treatment,” said Adam Feldman,
M.D., M.P.H., Urologic Oncologist in the Department of Urology at
Massachusetts General Hospital, and Director of the Combined
Harvard Urologic Oncology Fellowship. “Notably, there seems to be
no discernible difference in disease recurrence based on tumor
characteristics or timing of administration, including primary
chemoablation or post-endoscopic ablation. These results offer
additional evidence for the clinical utility of JELMYTO and may
also offer hope for improved long-term outcomes for our
patients.”
Furthermore, a different analysis of the same patient cohort,
presented by Yair Lotan, M.D., Professor of Urology and Chief of
Urologic Oncology at UT Southwestern and Parkland Health and
Hospital System and study investigator, reports that “maintenance
therapy with JELMYTO following successful induction treatment (n =
16) yielded a RFS rate of 100%, supplying more evidence of
JELMYTO’s pivotal role in treating this challenging condition,”
according to Dr. Lotan.
Data was collected from 15 centers on patients treated with
JELMYTO for upper tract urothelial cancers (UTUC). Recurrence-free
survival was calculated in 53 patients with LGTa disease at
baseline who had no evidence of disease following JELMYTO
induction. Chemoablative use was defined as the administration of
JELMYTO treatment in the setting of known residual UTUC, while
post-chemoablation use was defined as receipt of JELMYTO following
visually complete endoscopic ablation. Exploratory analyses were
performed to assess impact of size of tumor, presence of ureteral
involvement, and multifocality of UTUC prior to JELMYTO induction
on RFS at 24 months.
“These findings provide additional evidence reinforcing
JELMYTO's position as a valuable therapeutic option for patients
with low-grade upper tract urothelial cancer and add to the growing
body of real-world evidence in extending the long-term positive
outcomes for patients,” said Mark Schoenberg, MD, Chief Medical
Officer at UroGen. “This real-world evidence reaffirms JELMYTO's
role as a valuable tool in our fight against this disease.”
There were 136 cases of UTUC treated with JELMYTO with a
cumulative median (IQR) follow-up of 22 (12-27) months including
107 cases of LGTa UTUC. After initial treatment, 74% of
post-endoscopic ablation and 39% of chemoablative patients were
disease-free totaling 53 cases with LGTa UTUC without evidence of
disease following JELMYTO induction. The limitations of these
sub-analyses include the sample size, retrospective design, lack of
a control group, and the lack of a centralized pathology review and
standardized clinicopathologic assessment.
To further explore the full potential of JELMYTO for the
treatment of patients with UTUC, investigators are in the process
of enrolling the prospective and retrospective uTRACT Registry to
capture data in a large-scale, standardized manner to report
further on patient outcomes following JELMYTO treatment including
long-term longitudinal follow-up.
About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a
mitomycin-containing reverse thermal gel containing 4 mg mitomycin
per mL gel indicated for the treatment of adult patients with
low-grade-UTUC (LG-UTUC). It is approved for adult patients with
LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a
semi-solid gel at body temperature. The drug slowly dissolves over
four to six hours after instillation and is removed from the
urinary tract by normal urine flow and voiding. It is approved for
administration in a retrograde manner via ureteral catheter or
antegrade through nephrostomy tube. The delivery system allows the
initial liquid to coat and conform to the upper urinary tract
anatomy. The eventual semisolid gel allows for chemoablative
therapy to remain in the collecting system for four to six hours
without immediately being diluted or washed away by urine flow.
About Upper Tract Urothelial Cancer (UTUC)
Urothelial cancer is the ninth most common cancer globally and
the eighth most lethal neoplasm in men in the U.S. Between five
percent and ten percent of primary urothelial cancers originate in
the ureter or renal pelvis and are collectively referred to as
UTUC. In the U.S., there are approximately 6,000 - 7,000 new or
recurrent LG-UTUC patients annually. Most cases are diagnosed in
patients over 70 years old, and these older patients often face
comorbidities. There are limited treatment options for UTUC, with
the most common being endoscopic surgery or nephroureterectomy
(removal of the entire kidney and ureter). Treatment with
endoscopic surgery can lead to a high rate of recurrence and
relapse.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and
commercializing innovative solutions that treat urothelial and
specialty cancers because patients deserve better options. UroGen
has developed RTGel® reverse-thermal hydrogel, a proprietary
sustained-release, hydrogel-based platform technology that has the
potential to improve the therapeutic profiles of existing drugs.
UroGen’s sustained release technology is designed to enable longer
exposure of the urinary tract tissue to medications, making local
therapy a potentially more effective treatment option. Our first
product to treat LG-UTUC and investigational treatment UGN-102
(mitomycin) for intravesical solution for patients with low-grade
non-muscle invasive bladder cancer are designed to ablate tumors by
non-surgical means. UroGen is headquartered in Princeton, NJ with
operations in Israel. Visit www.urogen.com to learn more or follow
us on X (Twitter), @UroGenPharma.
Disclosure: Dr. Yair Lotan is a paid consultant to UroGen Pharma
Ltd.
APPROVED USE FOR JELMYTO
JELMYTO® is a prescription medicine used to treat adults with a
type of cancer of the lining of the upper urinary tract including
the kidney called low-grade Upper Tract Urothelial Cancer
(LG-UTUC).
IMPORTANT SAFETY INFORMATION
You should not receive JELMYTO if you have a hole or tear
(perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare provider about
all your medical conditions, including if you:
- are pregnant or plan to become pregnant. JELMYTO can harm your
unborn baby. You should not become pregnant during treatment with
JELMYTO. Tell your healthcare provider right away if you become
pregnant or think you may be pregnant during treatment with
JELMYTO. Females who are able to become pregnant: You should
use effective birth control (contraception) during treatment with
JELMYTO and for 6 months after the last dose. Males being
treated with JELMYTO: If you have a female partner who is able
to become pregnant, you should use effective birth control
(contraception) during treatment with JELMYTO and for 3 months
after the last dose.
- are breastfeeding or plan to breastfeed. It is not known if
JELMYTO passes into your breast milk. Do not breastfeed during
treatment with JELMYTO and for 1 week after the last dose.
- Tell your healthcare provider if you take water pills
(diuretic).
How will I receive JELMYTO?
- Your healthcare provider will tell you to take a medicine
called sodium bicarbonate before each JELMYTO treatment.
- You will receive your JELMYTO dose from your healthcare
provider 1 time a week for 6 weeks. It is important that you
receive all 6 doses of JELMYTO according to your healthcare
provider’s instructions. If you miss any appointments, call your
healthcare provider as soon as possible to reschedule your
appointment. Your healthcare provider may recommend up to an
additional 11 monthly doses.
- JELMYTO is given to your kidney through a tube called a
catheter.
- During treatment with JELMYTO, your healthcare provider may
tell you to take additional medicines or change how you take your
current medicines.
After receiving JELMYTO:
- JELMYTO may cause your urine color to change to a violet to
blue color. Avoid contact between your skin and urine for at least
6 hours.
- To urinate, males and females should sit on a toilet and
flush the toilet several times after you use it. After going to the
bathroom, wash your hands, your inner thighs, and genital area well
with soap and water.
- Clothing that comes in contact with urine should be washed
right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:
- Swelling and narrowing of the tube that carries urine from
the kidney to the bladder (ureteric obstruction). If you
develop swelling and narrowing, and to protect your kidney from
damage, your healthcare provider may recommend the placement of a
small plastic tube (stent) in the ureter to help the kidney drain.
Tell your healthcare provider right away if you develop side pain
or fever during treatment with JELMYTO.
- Bone marrow problems. JELMYTO can affect your bone
marrow and can cause a decrease in your white blood cell, red blood
cell, and platelet counts. Your healthcare provider will do blood
tests prior to each treatment to check your blood cell counts
during treatment with JELMYTO. Your healthcare provider may need to
temporarily or permanently stop JELMYTO if you develop bone marrow
problems during treatment with JELMYTO.
- The most common side effects of JELMYTO include: urinary
tract infection, blood in your urine, side pain, nausea, trouble
with urination, kidney problems, vomiting, tiredness, stomach
(abdomen) pain.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1800FDA1088. You may also report side effects to UroGen
Pharma at 1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including
the Patient Information, for additional information.
Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995, including, without limitation, statements regarding the
results from the real-world study of JELMYTO offering hope for
improved long-term outcomes for patients; the enrollment of the
prospective and retrospective data from the uTRACT Patient Registry
and plans to analyze and report on such data; the potential of
UroGen’s proprietary RTGel technology to improve therapeutic
profiles of existing drugs; and UroGen’s sustained release
technology making local delivery potentially more effective as
compared to other treatment options. These statements are subject
to a number of risks, uncertainties and assumptions, including, but
not limited to: results from of the real-world study of JELMYTO may
not be indicative of results that may be observed in future
clinical practice and may differ from additional analysis of the
data from the study or uTRACT Patient Registry; potential safety
and other complications from JELMYTO use in diverse UTUC patient
types; the ability to maintain regulatory approval; the ability to
obtain and maintain adequate intellectual property rights and
adequately protect and enforce such rights; complications
associated with commercialization activities; UroGen’s RTGel
technology may not perform as expected; and UroGen may not
successfully develop and receive regulatory approval of any other
product that incorporates UroGen’s RTGel technology. In light of
these risks and uncertainties, and other risks and uncertainties
that are described in the Risk Factors section of UroGen’s Annual
Report on Form 10-K for the year ended December 31, 2023, filed
with the SEC on March 14, 2024 (which is available at www.sec.gov),
the events and circumstances discussed in such forward-looking
statements may not occur, and UroGen’s actual results could differ
materially and adversely from those anticipated or implied thereby.
Any forward-looking statements speak only as of the date of this
press release and are based on information available to UroGen as
of the date of this release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240505867534/en/
INVESTOR CONTACT: Vincent Perrone Senior Director, Investor
Relations vincent.perrone@urogen.com 609-460-3588 ext. 1093
MEDIA CONTACT: Cindy Romano Director, Corporate Communications
cindy.romano@urogen.com 609-460-3583 ext. 1083
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